Oct. 23 Quick Takes: Merck drops two Kelun ADCs

Just after Merck & Co. Inc. (NYSE:MRK) announced its $4 billion upfront deal with Daiichi Sankyo Co. Ltd. (Tokyo:4568) for three clinical stage antibody-drug conjugates, the U.S. pharma said it won’t pursue two preclinical compounds with its other ADC partner, Sichuan Kelun-Biotech Biopharmaceutical Co. Ltd. (HKEX:6990). Kelun disclosed that on Oct. 21 Merck terminated an exclusive license for one program and declined to exercise an option for another. The assets are undisclosed. The companies had originally partnered across three ADC deals, which still include rights to three clinical programs targeting TROP2, CLDN18.2, and an undisclosed target, plus four additional preclinical programs. Earlier this month, Merck started the Phase III trial for TROP2-targeted ADC MK-2870 (SKB264) to treat non-small cell lung cancer (NSCLC). Shares of Kelun-Biotech fell 7% on Monday.

FDA has released draft guidance that is intended to help drug sponsors communicate with healthcare providers about unapproved uses of approved drugs. The guidance provides guidelines on sharing scientific reprints and other materials that can help healthcare providers make clinical practice decisions for individual patients. In the absence of guidance, sponsors may be reluctant to share information because of concerns about legal liability associated with off-label promotion...